Recent amendments have changed the systems governing post-market safety management of medical devices and responses to medical accidents. On September 22, 2026, the Ministry of Food and Drug Safety (MFDS) amended the Regulation on the Management of Safety Information, Including Adverse Events Related to Medical Devices. Major amendments to the Act on Remedies for Injuries from Medical Accidents and Mediation of Medical Disputes, announced by the Ministry of Health and Welfare, are also scheduled to take effect on May 27, 2027.

Although the two systems have different legal bases, medical device manufacturers and importers should note a common trend: post-market management of complaints, product issues, and medical accidents arising after a product is placed on the market is becoming increasingly important.

The most notable aspect of this MFDS notification amendment is that the scope of adverse events subject to reporting has been clarified. The previous condition – “when the Commissioner of the MFDS orders reporting (as other significant information or other adverse events)” – has been deleted. Product issues such as medical device defects or malfunctions that may potentially cause harm, even if they caused no actual health or clinical impact on a patient, are now expressly included among reportable events. Such product issues must be reported within one month after the end of the relevant quarter. 

For example, suppose a medical device temporarily stops working during a procedure, but the medical team promptly replaces it and the patient suffers no harm. Whereas the focus in the past might have been on the absence of patient harm, the reporting decision must now also assess whether the same malfunction could harm a patient if it recurs.

Manufacturers and importers should therefore review their internal procedures so that customer complaints, returns, repair records, device malfunctions, and software errors are not handled solely as quality issues, but are linked to complaint intake and safety assessment, leading to a decision on whether to report to the MFDS. The current regulation also includes within the scope of safety information collection not only serious adverse events, but cases that could lead to a serious adverse event if they recur, as well as safety measures taken by foreign governments.

From May 27, 2027, the systems concerning explanations of medical accidents, mediation and appraisal, and remedies for injuries will be strengthened. The amended law specifies the scope of “medical acts involving gross negligence.” Examples may include performing surgery or a transfusion on the wrong patient; leaving a medical device or foreign object inside the body during surgery; using the wrong type, dose, or route of a medication; or seriously violating essential safety management duties. 

Medical device companies should recognize that the cause of a medical accident is not always attributed solely to negligence by a healthcare professional. For example, if a medical device suddenly fails during surgery and a patient is injured, the investigation may consider whether the cause was a use error by the medical team, a defect or malfunction inherent to the device, or a maintenance issue. 

Manufacturers and importers should therefore have a system that allows them to promptly retrieve lot and serial information, manufacturing and release inspection records, repair and complaint histories, and risk management and CAPA records for a root-cause investigation following a medical accident. They should also establish in advance procedures for collecting and preserving the device involved and for investigation and reporting coordination with the overseas manufacturer.

To respond to these regulatory changes, companies should first verify whether their Complaint Handling and Adverse Event Reporting SOPs provide for the assessment of product issues even when no patient harm has occurred. Another key check is whether routine product complaints and repair information received by sales and service teams are escalated to the RA/QA team. 

In particular, companies importing and selling products from overseas manufacturers in Korea should clearly define their Safety Information Exchange procedures (Vigilance Agreement) between the Korean importer and the overseas manufacturer. Roles and responsibilities should be agreed in advance: when to notify the overseas manufacturer of adverse events occurring in Korea, who determines whether MFDS reporting is required, and who reviews, from a Korean regulatory perspective, safety issues involving the same product that arise overseas.

In light of these regulatory changes, MDREX supports medical device manufacturers and importers in reviewing their complaint and adverse event reporting systems, updating related SOPs, and determining and managing MFDS reporting obligations. We can also assist in establishing Safety Information Exchange procedures (Vigilance Agreements) between overseas manufacturers and Korean importers, and in building response frameworks for medical accidents. We invite you to use these amendments as an opportunity to review your company’s Post-Market Surveillance and Vigilance System.